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IRCT20240903062941N1 IRCT 2024-09-14 Esfahan University of Medical Sciences Investigating the effect of antibiotic administration on surgical complications of impacted and partially impacted mandibular third molars Investigating the effect of post-operative antibiotic administration on the complications of impacted and semi-impacted mandibular third molar surgery - a double-blinded randomized clinical trial 2024-09-22 anticipated 260 Complete https://irct.ir/trial/78874 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: This study is the first and only one to investigate the prophylactic efficacy of post-operative antibiotics in various anatomical variants of the mandibular third molar, considering them as potential determining factors for the need for prophylaxis and their effect on the severity of complications. In other words, in addition to assessing the overall effectiveness of antibiotics in reducing complications from this common procedure, the study aims to develop a protocol for prescribing prophylactic antibiotics based on unmodifiable pre-operative factors (in contrast to preventable factors such as a septic environment). This would enable dentists to confidently prescribe antibiotics only where necessary and avoid unnecessary overprescription. Furthermore, the presence of these anatomical variants and their potential role in the occurrence of complications could explain the significant controversies in related studies, as none of the previous research has examined these variants separately. As a result, the outcomes may differ depending on the extent to which these variants were included in the research, Randomization description: In this study, to balance the samples between the intervention and control groups, and considering the sample size in each of the confounding categories C3, C2, C1, B3, B2, the block randomization method is used for randomization. Accordingly, 13 blocks of 4 individuals are used for each of the mentioned categories. These 4-person blocks can be arranged in 6 different ways: (IICC, ICIC, ICCI, CIIC, CICI, CCII)*. Each of these arrangements is assigned a number from 1 to 6, and the sequence of 13 blocks in each category is determined by rolling a dice. Based on this, participants are assigned to either the intervention or control group. For instance, the following block sequence, determined by dice rolls, is one possible arrangement that can be used for randomization in categories C3, C2, C1, B3, B2: ICCI, ICIC, CCII, IICC, ICIC, CCII, CICI, CCII, CIIC, IICC, CCII, ICCI, ICIC Thus, in each of the confounding categories C3, C2, C1, B3, B2, 26 participants will be in the intervention group and 26 in the control group, resulting in a total of 130 samples in each of the overall control and intervention groups. The block sequences for each category (C3, C2, C1, B3, B2) and in general will be determined by a third party (other than the patient and the treating surgeon) as described. Accordingly, the patient will receive either a placebo or the medication. Neither the patient nor the surgeon will be informed about the block arrangement. *I = Intervention, C = Control, Blinding description: In this double-blind clinical trial, patients are enrolled after meeting the specified criteria. Then, based on the tooth in question, the patient is classified by the surgeon into one of the C3, C2, C1, B3, B2 categories according to the Pell & Gregory classification, using an OPG image and clinical examination. Before surgery, and during the initial evaluation, the criteria for maximum mouth opening and the length of the patient's soft tissue are assessed by the surgeon, and their status is recorded in the relevant forms. After surgery, patients from each of the C3, C2, C1, B3, B2 categories are randomly divided into the intervention and control groups by a third party using the block randomization method. Both groups are given similar packages (sealed container 49x58 with a sealed lid) containing 15 capsules. The capsules contain 500 mg of amoxicillin for the intervention group, and a similar placebo for the control group(blinding the patient by prescribing a similar capsule containing pharmaceutical grade starch placebo). Both the intervention and control groups are evaluated on the third and seventh days after surgery during follow-up sessions by a surgeon who is unaware of the substance the patient consumed(blinding of the clinical caregiver due to the presence of a third party and allocation of packages to patients by him). The evaluation includes the measurement of maximum mouth opening, following the same protocol as the initial evaluation. The length of the patient's soft tissue is also re-measured and recorded using the aforementioned method. Finally, any discharge of pus or serous fluid from the surgical site is examined and documented during these follow-up sessions through clinical examination. 2-3 Condition 1: Surgical site infection. Condition 2: Trismus (reduction of maximum mouth opening). Condition 3: Edema (swelling). Intervention 1: Intervention group: In this study, for the intervention group, instructions for taking 15 amoxicillin 500mg capsules (produced by Cosar Pharmaceutical Company) are prescribed, one every 8 hours for 5 days after the operation. It should be noted that the overall intervention group actually has a sample size of 130 people which based on the controlled factor ( The depth of impaction and the relation to the ramus in mandibular third molars) has been classified into 5 categories (C3, C2, C1, B3, B2) with a volume of 26 samples each. All 26 people in the intervention group of each category and accordingly all 130 overall intervention subjects receive the same medication protocol. Intervention 2: Control group: In this study, for the control group, the instructions for taking 15 placebo capsules (filled with pharmaceutical grade starch) are prescribed as one capsule every 8 hours for 5 days after the surgery. It should be noted that the overall control group consists of a sample size of 130 individuals, which is categorized into 5 groups (C3, C2, C1, B3, B2) based on the controlled factor (the depth of impaction and relation to the ramus in mandibular third molars), with each group containing 26 samples. All 26 participants in the control group of each category, and consequently all 130 in the overall control group, receive the same dosing protocol. Yes - There is a plan to make this available What will be shared: Information regarding the three main outcomes, namely surgical site infection, maximum mouth opening, and the length of the soft tissue from the tragus to menton, can be shared via a comprehensive Excel file after anonymizing the individuals. When: The access period starts three months after the completion of the study writing and the publication of the results. To whom: Researchers employed at academic and scientific institutions Conditions: Only researchers employed at academic and scientific institutions, whose job positions have been verified, can access the data tables for further analysis or aggregation with data from other studies after obtaining an ethics code from a reputable institution. The use of these documents is only permissible for examining the complications of impacted or semi-impacted mandibular third molar surgery. Where to obtain: To access the documents, applicants must contact the responsible individuals through one of the following methods: Phone number: 09035146324 - Mr. Ali Behnam Email 1: a.behnam1389@gmail.com - Mr. Ali Behnam Email 2: mahdi.2313@gmail.com - Dr. Mehdi Sadeghi How to obtain: Applicants must send their request via email along with their job qualification documents and the ethics code related to their research. If both components are approved on the relevant websites, the data file will be sent to them via email within two weeks in accordance with the above-mentioned (in the first field) principles. Comments:
public Mahdi Sadeghi
Oral and maxillofacial surgery departement,Isfahan school of dentistry,Sofeh Blvd
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 mahdi.2313@gmail.com Esfahan University of Medical Sciences scientific Mahdi Sadeghi
Oral and maxillofacial surgery departement,Isfahan school of dentistry,Sofeh Blvd
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 mahdi.2313@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Healthy individuals (ASA < 2) Age range: 16–35 years Having at least one impacted or semi-impacted wisdom tooth (categories C3, C2, C1, B3, B2 according to Pell & Gregory classification) in the mandible 16 years 35 years Both Individuals with poor oral hygiene (OHI-S < 3) Use of an interfering antibiotic that cannot be discontinued before the study Diagnosis of a systemic disease that interferes with the healing process (based on history-taking and clinical observations) History of pericoronitis in the past 7 days Discharge of pus or serous fluid from the surgical site Use of any immunosuppressive medication History of allergic reaction to penicillin family antibiotics History of allergic reaction to ibuprofen or other NSAIDs History of allergic reaction to chlorhexidine gluconate mouthwash T81.4 R25.2 R60.0 Infection following a procedure Cramp and spasm Localized edema Rehabilitation Placebo Intervention group: In this study, for the intervention group, instructions for taking 15 amoxicillin 500mg capsules (produced by Cosar Pharmaceutical Company) are prescribed, one every 8 hours for 5 days after the operation. It should be noted that the overall intervention group actually has a sample size of 130 people which based on the controlled factor ( The depth of impaction and the relation to the ramus in mandibular third molars) has been classified into 5 categories (C3, C2, C1, B3, B2) with a volume of 26 samples each. All 26 people in the intervention group of each category and accordingly all 130 overall intervention subjects receive the same medication protocol. Control group: In this study, for the control group, the instructions for taking 15 placebo capsules (filled with pharmaceutical grade starch) are prescribed as one capsule every 8 hours for 5 days after the surgery. It should be noted that the overall control group consists of a sample size of 130 individuals, which is categorized into 5 groups (C3, C2, C1, B3, B2) based on the controlled factor (the depth of impaction and relation to the ramus in mandibular third molars), with each group containing 26 samples. All 26 participants in the control group of each category, and consequently all 130 in the overall control group, receive the same dosing protocol. Maximum mouth opening. Timepoint: Measuring the amount of maximum mouth opening at the beginning of the study (before surgery) and 3 and 7 days after extraction surgery of the impacted or semi impacted mandibular third molar. Method of measurement: For the maximum mouth opening outcome, measuring the distance between the first right incisors in a state where the patient can open his/her mouth as much as possible without pain is used with the help of a measuring gauge. Surgical site infection. Timepoint: Examining the discharge of pus or serous 3 and 7 days after extraction surgery of the impacted or semi impacted mandibular third molar. Method of measurement: The discharge of pus or serous from the surgical site is examined in follow-up sessions with the help of clinical examination, and if it is positive then presence of infection is confirmed. Length of soft tissue from tragus to menton. Timepoint: Measuring the length of soft tissue from the tragus to the menton at the beginning of the study (before the surgery) and 3 and 7 days after extraction surgery of the impacted or semi impacted mandibular third molar. Method of measurement: For measuring the length of the patient's soft tissue, the mento-tragus length is used as an index. In this process, the two ends of the thread are passively placed on the Menton and Tragus landmarks, then marked. Finally, the thread is transferred onto a ruler, and the distance between the two marked points is recorded in millimeters. Esfahan University of Medical Sciences Approved 2024-03-13 Ethics Committee in Biomedical Research of Isfahan University of Medical Sciences Room 209 (permanent secretariat of the research ethics committee of the university),2nd floor, headquarters building No. 4, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan Isfahan Isfehan Iran (Islamic Republic of)